| CTRI Number |
CTRI/2026/01/102576 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of differnt time interval of cord clamping on anemia of 2 month of age . |
|
Scientific Title of Study
|
EFFECT OF TIMING OF UMBILICAL CORD CLAMPING ON PREVENTING EARLY INFANCY ANEMIA IN TERM AND PRETERM INFANTS - A RANDOMIZED CONTROL TRIAL
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apurva pareek |
| Designation |
Post Graduate student |
| Affiliation |
Dr S N medical college , jodhpur |
| Address |
Department of Pediatrics, Dr S. N. Medical College , Shastri Nagar , Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
8209586090 |
| Fax |
|
| Email |
apurva.chunnu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Singh |
| Designation |
Senior Professor |
| Affiliation |
Dr S N medical college , jodhpur |
| Address |
UNIT 1 , Department of Pediatrics, Dr S. N. Medical College , Shastri Nagar , Jodhpur
Additional Principal Chamber, Dr S. N. Medical College , Shastri Nagar , Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9414133692 |
| Fax |
|
| Email |
singha@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Apurva Pareek |
| Designation |
Post Graduate Student |
| Affiliation |
Dr S. N. medical college , jodhpur |
| Address |
Department of Pediatrics, Dr S.N. Medical College , Shastri Nagar , Jodhpur
Dr S.N. Medical College , Shastri Nagar , Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
8209586090 |
| Fax |
|
| Email |
apurva.chunnu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrS N medical college jodhpur |
| Address |
DrS N medical college , shastri nagar , jodhpur pin code 342002 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apurva pareek |
UMAID and MDM hospital |
Labour Room and NICU of UMAID AND MDM hospital , Department of pediatrics and Obstetrics and Gynecology, Dr S. N. Medical College, Shastri Nagar, Jodhpur, Rajasthan - 342001 , India.
Jodhpur
RAJASTHAN |
08209586090
apurva.chunnu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , Dr. Sampuranand Medical College , Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMAN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DELAYED CORD CLAMPING |
In the intervention group umbilical cord clamping will be performed at 90 seconds after birth or when cord pulsation stops whichever occurs later This is a two arm randomized controlled trial |
| Comparator Agent |
DELAYED CORD CLAMPING AT DIFFERENT TIME INTERVALS 60SECS 90 SECS WHEN PULSATION STOPS |
This is a two arm randomized controlled trial The control group will undergo umbilical cord clamping at 60 seconds after birth The intervention group will undergo delayed umbilical cord clamping at 90 seconds after birth or when cord pulsation stops whichever occurs later Outcomes will be compared between the two groups |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Month(s) |
| Gender |
Both |
| Details |
Term(below 41+-6 days of gestaional age ) and preterm (above 28 weeks of gestational age) |
|
| ExclusionCriteria |
| Details |
Multiple gestation
Major congenital malformation
Perinatal asphyxia and hie 3
Mother APH
SGA,IUGR newborn
Hydrops fetalis
Antenatal USG fetal anemia
Blood transfusion requiring newborns
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of different time interval of delayed cord clamping at 60 seconds , 90 seconds , when pulsation stopped on cord blood Hemoglobin level and Hemoglobin level at day 1, at 1 month and 2 month of age. |
Effect of different time interval of delayed cord clamping at 60 seconds , 90 seconds , when pulsation stopped on cord blood Hemoglobin level and Hemoglobin level at day 1, at 1 month and 2 month of age. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of delayed cord clamping at 60 seconds , 90 seconds , when pulsation stopped on
Neonatal jaundice
Polycythemia
Anthropometry. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (apurva.chunnu@gmail.com).
- For how long will this data be available start date provided 26-12-2025 and end date provided 20-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
•The RCT study will be conducted in LABOUR ROOM and NICU centre in UMAID and MDM hospital jodhpur after approval from the ethical review board of the institute. •After taking a written consent ,women admitted in labour room where randomly selected for delayed cord clamping at different time interval 60secs, 90 secs and when pulsation stops . • 2ml of cord blood will be collected in EDTA vacutainers under aseptic precautions and it will be sent to laboratory as early as possible. •Next , on day 1 cbc will be done for hemoglobin level and hematocrit at 24 hour . •to day 5 follow up to be done for development of neonatal jaundice , polycythemia , hypoglycemia , NICU admission , phototherapy duration , respiratory support need etc •At 1 month , follow up will be done , cbc to be done . •At 2 month , follow up will be done , cbc , sr ferritin , iron study to be done. |